A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 3 June 2013
• Main ID: NCT01400503
• Date of registration: 21/04/2011
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
• Scientific title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
• Date of first enrolment: April 2011
• Target sample size: 75
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01400503
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Belgium, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Israel, Korea, Republic of, New Zealand, Norway, Singapore, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has multicentric Castleman's disease

- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment
arm)

- Have had their last administration of study treatment (siltuximab or placebo) less
than 6 weeks (window of plus 2 weeks) prior to first dose

- Patients must not have had disease progression while receiving siltuximab. For those
patients originally assigned to placebo in the CNTO328MCD2001 study, patients who
have received less than 4 months of siltuximab following crossover will also be
eligible

- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose
of siltuximab for this study

Exclusion Criteria:

- Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of
consent as reason for discontinuing treatment from previous sponsor-initiated
siltuximab study

- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study

- Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies,
to murine, chimeric, human proteins or their excipients



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multicentric Castleman's Disease

Intervention(s)

Drug: Siltuximab

Primary Outcome(s)

Number of patients with adverse events [Time Frame: Up to 5 years]

Secondary Outcome(s)

Assessment of glycoform clearance analysis [Time Frame: Up to 6 weeks]

Assessment of in vivo protein degradation analysis [Time Frame: Up to 6 weeks]

Duration of multicentric Castleman's disease control [Time Frame: Up to death]

Duration of survival for patients with multicentric Castleman's disease [Time Frame: Up to death]

Multicentric Castleman's Disease Symptom Scale scores [Time Frame: Up to 12 weeks]

Number of multicentric Castleman's disease patients evaluated for assessment of atypical IL-6 splice variants or cleavage fragments [Time Frame: Up to 5 years]

Number of multicentric Castleman's disease patients evaluated for assessment of C-reactive protein [Time Frame: Up to 5 years]

Number of previously responding multicentric Castleman's disease patients and siltuximab-naive patients who maintain disease control [Time Frame: Up to 5 years]

Secondary ID(s)

2010-022837-27

CNTO328MCD2002

CR018469

Source(s) of Monetary Support

Please refer to primary and secondary sponsors